Archives of Dermatological Research

Arch Dermatol Res. 299(3): 111-138

German evidence-based guidelines for the treatment of Psoriasis vulgaris (short version)

A. Nast

info@psoriasis-leitlinie.de

¹, I. Kopp², M. Augustin³, K. B. Banditt⁴, W. H. Boehncke⁵, M. Follmann⁶, M. Friedrich⁷, M. Huber⁸, C. Kahl⁹, J. Klaus¹⁰, J. Koza¹⁰, I. Kreiselmaier¹¹, J. Mohr¹², U. Mrowietz¹¹, H. M. Ockenfels¹³, H. D. Orzechowski⁸, J. Prinz¹⁴, K. Reich¹⁵, T. Rosenbach¹⁶, S. Rosumeck⁹, M. Schlaeger¹⁷, G. Schmid-Ott¹⁸, M. Sebastian¹⁹, V. Streit²⁰, T. Weberschock⁵, B. Rzany⁹

1. Division of Evidence Based Medicine (dEBM), Klinik für Dermatologie, Venerologie, Allergologie, Charité–Universitätsmedizin Berlin, Schumannstrasse 20/21, 10117 Berlin, Germany

2. Ständige Kommission Leitlinien der AWMF, c/o Philipps-Universität Marburg, Institut für Theoretische Chirurgie, Marburg, Germany

3. Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für Dermatologie und Venerologie, Hamburg, Germany

4. Klinik für Dermatologie, Venerologie und Allergologie, Charité–Universitätsmedizin Berlin, Berlin, Germany

5. Zentrum der Dermatologie und Venerologie, Klinikum der Johann Wolfgang Goethe Universität, Frankfurt am Main, Germany

6. Division of Evidence Based Medicine (dEBM), Klinik für Dermatologie, Venerologie und Allergologie, Charité–Universitätsmedizin Berlin [since 1 February 2005: Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG)], Cologne, Germany

7. Klinik für Dermatologie, Venerologie und Allergologie, Charité–Universitätsmedizin Berlin [since 1 January 2006: Intendis GmbH], Berlin, Germany

8. Institut für Klinische Pharmakologie und Toxikologie, Charité–Universitätsmedizin Berlin, Berlin, Germany

9. Division of Evidence Based Medicine (dEBM), Klinik für Dermatologie, Venerologie, Allergologie, Charité–Universitätsmedizin Berlin, Schumannstrasse 20/21, 10117 Berlin, Germany

10. Deutscher Psoriasis Bund e.V, Hamburg, Germany

11. Klinik für Dermatologie, Venerologie, Allergologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel, Germany

12. Abteilung Dermatologie und Venerologie, Hautklinik und Poliklinik der Georg-August-Universität Göttingen, Göttingen, Germany

13. Haut- u. Allergieklinik, Klinikum Hanau, Hanau, Germany

14. Klinik und Poliklinik für Dermatologie und Allergologie, Klinikum der Ludwig Maximilian Universität München, Munich, Germany

15. Abteilung Dermatologie und Venerologie, Hautklinik und Poliklinik der Georg-August-Universität Göttingen (current: Dermatologikum Hamburg, Prof. Steinkraus und Partner), Göttingen, Germany

16. Osnabrück, Germany

17. Oldenburg, Germany

18. Abteilung Psychosomatik und Psychotherapie, Medizinische Hochschule Hannover, Hannover, Germany

19. Mahlow, Germany

20. Buchholz, Germany

© Springer-Verlag 2007

DOI: 10.1007/s00403-007-0744-y

Published online: 12 May 2007

Published in print: June 2007

Abstract

Psoriasis vulgaris is a common and chronic inflammatory skin disease which has the potential to significantly reduce the quality of life in severely affected patients. The incidence of psoriasis in Western industrialized countries ranges from 1.5 to 2%. Despite the large variety of treatment options available, patient surveys have revealed insufficient satisfaction with the efficacy of available treatments and a high rate of medication non-compliance. To optimize the treatment of psoriasis in Germany, the Deutsche Dermatologische Gesellschaft and the Berufsverband Deutscher Dermatologen (BVDD) have initiated a project to develop evidence-based guidelines for the management of psoriasis. The guidelines focus on induction therapy in cases of mild, moderate, and severe plaque-type psoriasis in adults. The short version of the guidelines reported here consist of a series of therapeutic recommendations that are based on a systematic literature search and subsequent discussion with experts in the field; they have been approved by a team of dermatology experts. In addition to the therapeutic recommendations provided in this short version, the full version of the guidelines includes information on contraindications, adverse events, drug interactions, practicality, and costs as well as detailed information on how best to apply the treatments described (for full version, please see Nast et al., JDDG, Suppl 2:S1–S126, 2006; or http://www.psoriasis-leitlinie.de).

Introduction

The Deutsche Dermatologische Gesellschaft (DDG) and the Berufsverband Deutscher Dermatologen (BVDD) have initiated a project to develop evidence-based guidelines for the treatment of plaque psoriasis. The full version of the Guidelines has been published in the Journal der Deutschen Dermatologischen Gesellschaft (JDDG 2006 Suppl 2) and is available at http://www.psoriasis-leitlinie.de [149]. This article summarizes the key points of the Guidelines.

Background

Psoriasis vulgaris is a common and chronic inflammatory skin disease which has the potential to significantly reduce the quality of life in severely affected patients. The incidence of psoriasis in Western industrialized countries is 1.5–2% [2]. Studies on the impairment of life quality have shown that, depending on the severity of the disease, a significant burden may exist in the form of a disability or psychosocial stigmatization [3]. Patient surveys have shown that the mental and physical impairment associated with psoriasis is comparable to that of other significant chronic conditions, such as type 2 diabetes or chronic respiratory diseases [4].

Patient surveys have shown that only 25% of psoriasis patients are highly satisfied with the outcome of their treatment, another 50% indicate moderate satisfaction, and approximately 20% report low treatment satisfaction [5]. In addition, there is a high non-compliance rate in the intake of medication of up to 40% [1].

Experience has shown that treatment selection for patients with psoriasis vulgaris is more commonly based on traditional concepts than on evidence-based data on the efficacy of various therapeutic options. In addition, it appears that systemic therapies are occasionally not applied in situations where they are needed due to the increased effort involved in monitoring the patients for unwanted side effects and possible interactions with other drugs.

Goal of the Guidelines

The overall objective of the Guidelines is to provide dermatologists in clinics and private practice with an accepted and evidence-based decision-making tool for the selection and implementation of a suitable and efficacious treatment for patients with psoriasis vulgaris. The focus of the Guidelines is on the induction therapy of mild, moderate, and severe plaque-type psoriasis in adults.

Physicians’ personal experiences and traditional therapeutic concepts should be supplemented and, if necessary, replaced by an evidence-based assessment of the efficacy of individual therapies in psoriasis vulgaris.

The guidelines provide in-depth explanations of the available systemic and topical treatments for psoriasis, including the different photo- and photochemical therapies, and provide detailed descriptions of the administration and safety aspects.

By providing background information on the profile of the available drugs, including efficacy, safety, and aspects of practicality and costs, the Guidelines should facilitate the process of selecting an appropriate treatment for each individual patient. This should help increase compliance and optimize the benefit/risk ratio of psoriasis therapies.

Methods

A detailed description of the methodology employed in developing the Guidelines can be found in the Method Report on the Guidelines (http://www.psoriasis-leitlinie.de).

Basis of data

A systematic search of the literature was carried out in May 2005 with the objective of assessing the effectiveness of individual therapeutic options. This search yielded 6,224 publications of which 142 studies fulfilled the inclusion criteria for the Guidelines (see Box 1) and were therefore included in the assessment of the effectiveness of the relevant treatment. Various other aspects were evaluated on the basis of information presented in available literature, without a systematic analysis, and the years of personal experience of the experts.

Evidence assessment

The efficacy and effectiveness of each intervention was evaluated using evidence-based criteria.

The methodological quality of each individual study was assessed using the following grades of evidence (GE):

A₁

Meta-analysis that includes at least one randomized study with grade A₂ evidence. In addition, the results of the different studies included in the meta-analysis must be consistent with one another.

A₂

A high-quality (e.g. sample-size calculation, flow chart, intention-to-treat (ITT) analysis, sufficient size) randomized, double-blind comparative clinical study.

B

Randomized clinical study of lesser quality or other comparative study (non-randomized, cohort, or case-control study).

C

Non-comparative study.

D

Expert opinion.

Individual interventions (i.e., as monotherapy) were rated according to the following levels of evidence (LE):

Intervention is supported by studies with grade A1 evidence or studies with grade A₂ evidence whose results are predominantly consistent with one another.

Intervention is supported by studies with grade A₂ evidence or studies with grade B evidence whose results are predominantly consistent with one another.

Intervention is supported by studies with grade B evidence or studies with grade C evidence whose results are predominantly consistent with one another.

Little or no systematic empirical evidence

Therapeutic recommendation

A distinct rating of the therapeutic options or a strict clinical algorithm cannot be defined for the treatment of psoriasis vulgaris. The criteria for selecting a particular therapy are complex. The decision for a specific treatment should be based on the profile of the available drugs and the characteristics of a given patient. The decision for or against a therapy remains a case-by-case decision. These Guidelines provide a reasonable form of assistance in deciding on a suitable therapy and are an instrument for optimizing the required therapeutic process.

The recommendations formulated in the text are supported graphically in selected key recommendations by the following indications of the strength of the therapeutic recommendation:

↑↑

Measure is highly recommended

↑

Measure is recommended

→

Neutral

↓

Measure is not recommended

↓↓

Measure is highly inadvisable

The strength of the recommendation reflects both a treatment’s efficacy and the level of evidence supporting it as well as aspects of safety, practicality, and the cost/benefit ratio. A consensus on the strength of the recommendation was reached during the Consensus Conference.

Results

Therapeutic options are named and discussed in alphabetical order.

Therapeutic strategies

Fig. 1View larger versionFig. 1. Overview of the therapeutic options evaluated for chronic plaque psoriasis (the therapeutic options are listed alphabetically and do not represent a ranking)

Evaluation of topical and systemic therapies in tabular form

These tables are intended to provide a rough orientation for evaluating the therapeutic options. Cumulative calculations of the individual aspects for the overall evaluation of the therapeutic options are not possible and cannot be drawn upon for the final analysis of a therapeutic option. The product assessment for each individual patient may deviate greatly. A direct comparison between systemic and topical therapies is not possible because of the different severity of the psoriasis lesions of patients treated with topical or systemic treatments. The evaluations reported here were made on the basis of data extracted from the literature and expert opinions.

For further details refer to the Methods Report at www.psoriasis-leitlinie.de

Topical monotherapy

Phototherapy and systemic monotherapy

(a) Efficacy The evaluation of the efficacy column reflects the percentage of patients who achieved a reduction in the baseline Psoriasis Area and Severity Index (PASI) of ≥75%.

See full table

The evidence level applies only to the estimate of efficacy.

(b) Safety/tolerance in induction therapy or maintenance therapy This refers to the risk of occurrence of severe adverse drug reactions or the probability of adverse drug reactions that would result in the discontinuation of therapy.

(c) Practicality (Patient) This evaluation analyzes the effort involved in handling and administrating the treatment regimen by the patient.

(d) Practicality (Physician) This aspect considers the amount of work (documentation, explanation, monitoring), personnel and equipment needs, time for physician/patient interaction, remuneration of therapeutic measures, invoicing difficulties/risk of recourse claims from the health insurance companies.

(e) Cost/benefit Consideration of the costs of an induction therapy or a maintenance therapy.

The evaluations of safety/tolerance in induction therapy or maintenance therapy as well as practicality for the physician or patient and the cost/benefit were performed using a scale ranging from poor (–) to good (++++). The gradation between these two extremes was made based on expert opinion and unsystematic literature search. A level of evidence was not given for these evaluations since no systematic literature review was performed.

Evaluation of topical therapies

Calcineurin inhibitors

See full tableTable 1. Tabular summary

Corticosteroids

See full tableTable 2. Tabular summary

Coal tar

See full tableTable 3. Tabular summary

Dithranol

See full tableTable 4. Tabular summary

Tazarotene

See full tableTable 5. Tabular summary

Vitamin D₃ and analogues

See full tableTable 6. Tabular summary

Phototherapy

See full tableTable 7. Tabular summary

Evaluation of systemic therapies

Efalizumab

See full tableTable 8. Tabular summary

See full tableTable 9. Laboratory controls during treatment with efalizumab

Etanercept

See full tableTable 10. Tabular summary

See full tableTable 11. Laboratory controls during treatment with etanercept

Infliximab

See full tableTable 12. Tabular summary

See full tableTable 13. Laboratory controls during treatment with infliximab

Cyclosporine

See full tableTable 14. Tabular summary

See full tableTable 15. Laboratory controls during treatment with cyclosporine

Fumaric acid esters

See full tableTable 16. Tabular summary

See full tableTable 17. Dosage regimen for Fumaderm therapy

See full tableTable 18. Laboratory controls during treatment with fumaric acid esters

Methotrexate

See full tableTable 19. Tabular summary

See full tableTable 20. Laboratory controls during treatment with MTX [137]

Retinoids

See full tableTable 21. Tabular summary

aDouble contraception is recommended (e.g., condom + pill; IUD/Nuva-Ring + pill; cave: no low-dosed progesterone preparations/mini-pills) during and up to 2 years after the end of therapy; effectiveness is reduced by acitretin

See full tableTable 22. Laboratory controls during treatment with Acitretin

Other therapies

Climate/balneotherapy

See full tableTable 23. Tabular summary

Psychosocial therapy

Notes on the use of the Guidelines

The presentation of the therapies deliberately focused on those aspects deemed particularly relevant by a panel of experts. Aspects which are not of specific importance for a certain intervention, but which are part of the physician’s general obligations to the patient, such as the investigation of intolerance and allergies toward certain drugs or the exclusion of contraindications, are not individually listed, but it is nevertheless taken for granted that these are part of the physician’s duty to provide care.

It is recommended that each and every user carefully reads and follows the product information and compare it with the recommendations in the Guidelines on dosaging, contraindications, and drug interactions for completeness and currentness. Every dose or application is administered at the user’s own risk. The authors and the publishers kindly request that users inform them of any inaccuracies that they might notice. The users are requested to keep themselves constantly informed of any new findings subsequent to the publication of the Guidelines.

Acknowledgments

The guidelines were generated upon request by the Deutsche Dermatologische Gesellschaft (DDG) and the Berufsverband Deutscher Dermatologen (BVDD). The project was supported by the ‘Förderverein der Deutschen Dermatologischen Gesellschaft’, the funding body of the DDG.

Conflicts of interests All authors have filled in specific forms to declare their conflicts of interests. These forms are available online under www.psoriasis-leitlinie.de. The experts involved in drawing up these guidelines received no payments for their work other than travel expenses.

Footnotes

With kind permission of Deutsche Dermatologische Gesellschaft.

An enhanced version of these guidelines has been published with Blackwell in 2006.

Articles from Archives of Dermatological Research are provided here courtesy of Springer

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Kragballe K, Jansen CT, Geiger JM, Bjerke JR, Falk ES, Gip L, Hjorth N, Lauharanta J, Mork NJ, Reunala T, et al., authors. A double-blind comparison of acitretin and etretinate in the treatment of severe psoriasis. Results of a Nordic multicentre study. Acta Derm Venereol. 1989. 69(1):p. 35–40 Kragballe K, Jansen CT, Geiger JM, Bjerke JR, Falk ES, Gip L, Hjorth N, Lauharanta J, Mork NJ, Reunala T et al (1989) A double-blind comparison of acitretin and etretinate in the treatment of severe psoriasis. Results of a Nordic multicentre study Acta Derm Venereol 69(1):35–40 [PubMed]

Gupta AK, Goldfarb MT, Ellis CN, Voorhees JJ, authors. Side-effect profile of acitretin therapy in psoriasis. J Am Acad Dermatol. 1989. 20(6):p. 1088–1093 Gupta AK, Goldfarb MT, Ellis CN, Voorhees JJ (1989) Side-effect profile of acitretin therapy in psoriasis. J Am Acad Dermatol 20(6):1088–1093 [PubMed]

Carlin CS, Callis KP, Krueger GG, authors. Efficacy of acitretin and commercial tanning bed therapy for psoriasis. Arch Dermatol. 2003. 139(4):p. 436–442. [Cross Ref] Carlin CS, Callis KP, Krueger GG (2003) Efficacy of acitretin and commercial tanning bed therapy for psoriasis. Arch Dermatol 139(4):436–442 [PubMed]

Halevy S, Giryes H, Friger M, Sukenik H, authors. Dead sea bath salt for the treatment of psoriasis vulgaris: a double- blind controlled study. J Eur Acad Dermatol Venereol. 1997. 9(3):p. 237–242. [Cross Ref] Halevy S, Giryes H, Friger M, Sukenik H (1997) Dead sea bath salt for the treatment of psoriasis vulgaris: a double- blind controlled study. J Eur Acad Dermatol Venereol 9(3):237–242

Robertson DB, McCarty JR, Jarratt M, authors. Treatment of psoriasis with 8-methoxypsoralen and sunlight. South Med J. 1978. 71(11):p. 1345–1349 Robertson DB, McCarty JR, Jarratt M (1978) Treatment of psoriasis with 8-methoxypsoralen and sunlight. South Med J 71(11):1345–1349 [PubMed]

Fleischer ABJ, Clark AR, Rapp SR, Reboussin DM, Feldman SR, authors. Commercial tanning bed treatment is an effective psoriasis treatment:results from an uncontrolled clinical trial. J Invest Dermatol. 1997. 109(2):p. 170–174. [Cross Ref] Fleischer ABJ, Clark AR, Rapp SR, Reboussin DM, Feldman SR (1997) Commercial tanning bed treatment is an effective psoriasis treatment:results from an uncontrolled clinical trial. J Invest Dermatol 109(2):170–174 [PubMed]

Fortune DG, Richards HL, Kirby B, Bowcock S, Main CJ, Griffiths CE, authors. A cognitive-behavioural symptom management programme as an adjunct in psoriasis therapy. Br J Dermatol. 2002. 146(3):p. 458–465. [Cross Ref] Fortune DG, Richards HL, Kirby B, Bowcock S, Main CJ, Griffiths CE (2002) A cognitive-behavioural symptom management programme as an adjunct in psoriasis therapy. Br J Dermatol 146(3):458–465 [PubMed]

Tausk F, Whitmore SE, authors. A pilot study of hypnosis in the treatment of patients with psoriasis. Psychother Psychosom. 1999. 68(4):p. 221–225. [Cross Ref] Tausk F, Whitmore SE (1999) A pilot study of hypnosis in the treatment of patients with psoriasis. Psychother Psychosom 68(4):221–225 [PubMed]

Nast A, Kopp I, Augustin M), Banditt KB, Boehncke WH, Follmann M, Friedrich M, Huber M, Kahl C, Klaus J, Koza J, Kreiselmaier I, Mohr J, Mrowietz U, Ockenfels HM, Orzechowski HD, Prinz J, Reich K, Rosenbach T, Rosumeck S, Schlaeger M, Schmid-Ott G, Sebastian M, Streit V, Weberschock T, Rzany B (2006) S3-Leitlinie zur Therapie der Psoriasis vulgaris. JDDG Suppl 2:S1–S126

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Fig. 1.

Overview of the therapeutic options evaluated for chronic plaque psoriasis (the therapeutic options are listed alphabetically and do not represent a ranking)

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Scale | Systemic therapy | Topical therapy
++++ | Approx. 90% | Approx. 60%
+++ | Approx. 70% | Approx. 45%
++ | Approx. 50% | Approx. 30%
+ | Approx. 30% | Approx. 15%
+/− | Approx. 10% | Approx. 5%
– | Not defined | Not defined

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Table 1.

Tabular summary

Calcineurin inhibitors

First approved in Germany

 Pimecrolimus (Elidel®)
2002 (Atopic dermatitis, not approved for psoriasis vulgaris)

 Tacrolimus (Protopic®)
2002 (Atopic dermatitis, not approved for psoriasis vulgaris)

Recommended initial dosage
Pimecrolimus cream: 1× to 2× daily
Tacrolimus: 1× to 2× daily (application on the face: Begin with 0.03% salve; increase later dosage to 0.1% salve)

Recommended maintenance dosage
Individual therapeutic adjustment

Expected beginning of clinical effect
After approximately 2 weeks

Response rate
No data available

Important contraindications
Pregnancy and nursing (due to lack of experience) skin infections, immune suppression

Important adverse drug reactions (ADRs)
Burning sensation on skin, skin infections

Important drug interactions
None known

Other
Cave: Do not combine with phototherapy! Photoprotection!

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Table 2.

Tabular summary

Corticosteroids
First approved in Germany | 1956 (Psoriasis vulgaris)
Recommended control parameters | None
Recommended initial dosage | One to two times daily
Recommended maintenance dosage | Gradual reduction following onset of effect
Expected beginning of clinical effect | After 1–2 weeks
Response rate | Betamethasone dipropionate, two times daily: marked improvement or clearance of the skin lesions in 46–56% patients after 4 weeks (LE 1)
Important contraindications | Skin infections, rosacea, perioral dermatitis
Important ADRs | Skin infections, perioral dermatitis, skin atrophy, hypertrichosis, striae
Important drug interactions | None
Other | –

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Table 3.

Tabular summary

Coal tar
First approved in Germany | Listed active ingredient since 2000 (DAC on page 170), historical application, various tar-containing externals are licensed as drugs, application of tar as anti-psoriatic following publication by Goeckermann in 1925
Recommended control parameters | After long-term application/application on large areas: if needed clinical controls for potential development of skin carcinoma
Recommended initial dosage | 5–20% salve preparations or gels for local therapy, 1× daily
Recommended maintenance dosage | No long-term application (max. 4 weeks, DAC 2000)
Expected beginning of clinical effect | After 4–8 weeks, efficacy improves in combination with UV application
Response rate | There is insufficient data available on the response rate as a monotherapy (LE 4)
Important contraindications | Pregnancy and nursing
Important ADRs | Color, odor, carcinogenic risk, phototoxicity—which is part of the desired effect
Important drug interactions | Not known with topical use
Other | DAC 2000 (on page 170), Hazardous Goods Directive Appendix 4 No. 13

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Table 4.

Tabular summary

Dithranol
First approved in Germany
Psoralon | 1983 (Psoriasis vulgaris)
Psoradexan | 1994 (Psoriasis vulgaris)
Micanol | 1997 (Psoriasis vulgaris)
Recommended control parameters | Intensity of irritation
Recommended initial dosage | Begin with 0.5% preparation for long-term therapy or 1% for short-contact therapy, then increase if tolerated
Recommended maintenance dosage | Not recommended for maintenance therapy
Expected beginning of clinical effect | After 2–3 weeks
Response rate | Marked improvement or clearance of skin lesions in 30–50% of the patients (LE 2)
Important contraindications | Acute, erythrodermic forms of psoriasis vulgaris; pustular psoriasis
Important ADRs | Burning and reddening of the skin in >10%
Important drug interactions | –
Other | –

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Table 5.

Tabular summary

Tazarotene
First approved in Germany | 1997 (psoriasis vulgaris)
Recommended control parameters | Check development of skin irritations
Recommended initial dosage | Begin with one treatment daily of tazarotene gel 0.05% in the evening for approximately 1–2 weeks
Recommended maintenance dosage | If necessary continue for 1–2 weeks with tazarotene gel 0.1%
Expected beginning of clinical effect | After 1–2 weeks
Response rate | After 12 weeks therapy with 0.1% tazarotene gel improved findings of at least 50% in approximately 50% of the patients (LE 2)
Important contraindications | Pregnancy, nursing
Important ADRs | Pruritus, burning sensation of skin, erythema, irritation
Important drug interactions | Avoid concomitant use of preparations with irritating and drying properties
Other | –

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Table 6.

Tabular summary

Vitamin D₃ and analogues
First approved in Germany
 Calcipotriol | 1992 (Psoriasis vulgaris)
 Tacalcitol | 1994 (Psoriasis vulgaris)
 Calcitriol | 1999 (Psoriasis vulgaris)
 Calcipotriol/Betamethasone | 2002 (Psoriasis vulgaris)
Recommended control parameters | Monitor for skin irritations
Recommended initial dosage | Calcipotriol: 1× to 2× daily to affected locations, up to a maximum of 30% of the body surface
Tacalcitol: 1× daily to affected locations, up to a maximum of 20% of the body surface
Calcitriol: 2× daily to affected locations, up to a maximum of 35% of the body surface
Recommended maintenance dosage | Calcipotriol: 1× to 2× daily, up to 100 g/week for up to 1 year
Tacalcitol: 1× daily for 8 weeks, for up to 18 months, on a maximum of 15% of the body surface with up to 3.5 g daily
Calcitriol: insufficient experience with the application for more than 6 weeks
Expected beginning of clinical effect | After 1–2 weeks
Response rate | Between 30 and 50% of the patients demonstrated a marked improvement or clearance of the lesions after 4–6 weeks (LE 1)
Important contraindications | Diseases with abnormal calcium metabolism, severe liver and renal diseases
Important ADRs | Skin irritation (reddening, itching, burning)
Important drug interactions | Drugs which elevate the calcium levels, (e.g. thiazide diuretics), no concomitant application of topical salicylic acid preparations (inactivation)
Other | Exposure to UV light results in inactivation of the vitamin D₃-analogues

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Table 7.

Tabular summary

Phototherapy

First approved in Germany
Clinical experience, depending on the modality for >50 years

Recommended control parameters
Regular skin inspection (UV erythema)

Recommended initial dosage
Individual dose depends on skin type; options:

• UVB: 70% of minimum erythema dose (MED)

• Oral PUVA (photochemotherapy): 75% of the minimum phototoxic dose (MPD)

• Bath/cream PUVA: 20–30% of MPD

Recommended maintenance dosage
Increase according to degree of UV erythema

Expected beginning of clinical effect
After 1–2 weeks

Response rate
In >75% of the patients PASI, 75 after 4–6 weeks (LE 2)

Important contraindications
Photo-dermatoses/photosensitive diseases, skin malignancies, immunosuppression
Only PUVA: pregnancy and nursing

Important ADRs
Erythema, itching, blistering, malignancies
Only oral PUVA: nausea

Important drug interactions
Drugs causing phototoxicity or photoallergy

Other
Combination with topical preparations acts synergistically, PUVA may not be combined with cyclosporine

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Table 8.

Tabular summary

Efalizumab
First approved in Germany | September 2004 (psoriasis vulgaris)
Recommended control parameters | Prior to therapy exclusion of significant infections, complete blood count, liver values
Recommended initial dosage | 0.7 mg/kg body weight (BW) per week
Recommended maintenance dosage | 1 mg/kg BW per week
Expected beginning of clinical effect | After 4–8 weeks
Response rate | PASI 75 for approximately 30% of the patients after 12 weeks (LE 1)
Important contraindications (limited selection) | Chronic or acute infections, pregnancy, malignant diseases, immune deficiencies, no vaccinations before or during treatment
Important ADRs (limited selection) | Flu-like injection reactions, leukocytosis and lymphocytosis, rebound, exacerbation and arthralgia, thrombocytopenia
Important drug interactions | Not known
Other | Stop therapy due to the risk of exacerbation and rebound if a PASI reduction of 50% is not achieved after 12 weeks

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Table 9.

Laboratory controls during treatment with efalizumab

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Table 10.

Tabular summary

Etanercept
First approved in Germany | 2002 (Psoriasis arthritis )/2004 (psoriasis vulgaris)
Recommended control parameters | Prior to therapy exclusion of tuberculosis, complete blood count, liver and renal values, urinanalysis
Recommended initial dosage | Twice 25 mg per week or 2× 50 mg/week
Recommended maintenance dosage | Twice 25 mg per week
Expected beginning of clinical effect | After 4–8 weeks, at the latest after 12 weeks
Response rate | PASI 75 in 34% (2 × 25 mg) or 49% (2 × 50 mg) of the patients at the end of the induction phase (12 weeks) (LE 1)
Important contraindications (limited selection) | Infections, pregnancy, nursing, heart failure NYHA III–IV
Important ADRs (limited selection) | Local reactions, infections
Important drug interactions (limited selection) | Anakinra (IL-1 receptor antagonist)
Other | –

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Table 11.

Laboratory controls during treatment with etanercept

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Table 12.

Tabular summary

Infliximab
First approved in Germany | 2004 (Psoriasis arthritis)/2005 (psoriasis vulgaris)
Recommended control parameters | Prior to therapy exclusion of tuberculosis, during therapy: leukocyte and platelet counts, liver value controls, signs of clinical infection
Recommended initial dosage | 5 mg/kg BW at week 0, 2, 6
Recommended maintenance dosage | 5 mg/kg BW in dosage intervals of 8 weeks
Expected beginning of clinical effect | After 1–2 weeks
Response rate | PASI 75 in ≥80% of the patients with moderate to severe psoriasis vulgaris (LE 1)
Important contraindications (limited selection) | Acute or chronic infections, tuberculosis, cardiac failure NYHA III–IV, pregnancy and nursing
Important ADRs (limited selection) | Infusion reactions, severe infections, progression of heart failure NYHA III–IV, very rare liver failure, autoimmune phenomena
Important drug interactions (limited selection) | Anakinra (IL-1 receptor antagonist)
Other | –

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Table 13.

Laboratory controls during treatment with infliximab

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Table 14.

Tabular summary

Cyclosporine

First approved in Germany
1983 (Transplantation medicine)

1993 (Psoriasis vulgaris)

Recommended control parameters
Interview/examination:

• Status of skin and mucous membranes

• Signs of infection

• Neurological, gastrointestinal symptoms

• Blood pressure

Laboratory controls: see Table 14

Recommended initial dosage
2.5–3 (max. 5) mg/kg BW

Recommended maintenance dosage
Interval therapy (between 8 and 16 weeks) with dosage reduction at the end of the induction therapy (e.g., 0.5 mg/kg BW every 14 days) or

Continuous long-term therapy with dosage reduction (e.g. by 50 mg every 4 weeks after week 12) and a dosage increase by 50 mg with relapse

Maximum total duration of therapy: 2 years

Expected beginning of clinical effect
After approximately 4 weeks

Response rate
Dose-dependent: after 8–16 weeks with 3 mg/kg BW; PASI 90 in approximately 30–50% of patient and PASI 75 in approximately 50–70% of patients (LE 1)

Important contraindications (limited selection)
Absolute:

Reduced renal function, insufficiently controlled arterial hypertension, uncontrolled infections, relevant malignancies (current or previous, in particular hematologic diseases and cutaneous malignancies with the exception of basal cell carcinoma)

Relative:

Relevant hepatic dysfunction, pregnancy and nursing, concomitant use of substance which interacts with cyclosporine, concomitant UV-therapy or prior PUVA-pre-therapy with cumulative dosage >1000 J/cm², concomitant application of other immunosuppressives, retinoids or long-term prior-therapy with methotrexate (MTX)

Important ADRs (limited selection)
Renal failure, increase of blood pressure, liver failure, nausea, anorexia, vomiting, diarrhea, hypertrichosis, gingival hyperplasia, tremor, weariness, parasthesia, hyperlipidemia

Important drug interactions (limited selection)
Increase of the cyclosporine level (CYP3A inhibition) through:

Allopurinol, calcium antagonists, amiodarone, antibiotics (macrolides, clarithromycin, josamycin, ponsinomycin, pristinamycin, doxycycline, gentamicin, tobramycin, ticarcillin, quinolones), ketoconazole, oral contraceptives, methylprednisolone (high dosages), ranitidine, cimetidine, grapefruit juice

Decrease of the cyclosporine level (CYP3A induction) through: Carbamazepine, phenytoin, barbiturates, metamizole, St. John’s wort

Possible reinforcement of nephrotoxic adverse drug reactions through: Aminoglycosides, amphotericin B, ciprofloxacin, acyclovir, non-steroidal antiphlogistics

Specific interactions:

Potassium-saving substances: increased risk of hyperpotassemia

Reduced clearance of: Digoxin, colchicine, prednisolone, HMG-CoA reductase inhibitors (e.g. lovastatin), diclofenac

Other
Increased risk of lympho-proliferative diseases in transplant patients. Increased risk of squamous cell carcinoma in psoriasis patients following excessive phototherapy.

Only moderately effective in and not approved for psoriatic arthritis

Also used successfully in the therapy of chronic-inflammatory diseases in children

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Table 15.

Laboratory controls during treatment with cyclosporine

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Table 16.

Tabular summary

Fumaric acid esters
First approved in Germany | 1995 (Psoriasis vulgaris)
Recommended control parameters | Serum creatinine, transaminases/γGT, complete blood count including differential blood count, urinanalysis
Recommended initial dosage | According to recommended dosage regimen see Table 17
Recommended maintenance dosage | Individually adapted dosage
Expected beginning of clinical effect | After approximately 6 weeks
Response rate | PASI 75 in 50–70% of the patients at the end of the induction phase after 16 weeks (LE 2)
Important contraindications (limited selection) | Chronic diseases of the gastrointestinal tract and/or the kidneys and chronic diseases, which are accompanied by an impairment of the leukocyte count or functions, malignant diseases, pregnancy and nursing
Important ADRs (limited selection) | Gastrointestinal complaints, flush, lymphopenia, eosinophilia
Important drug interactions | None known
Other | –

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Table 17.

Dosage regimen for Fumaderm therapy

| Fumaderm initial | Fumaderm
Week 1 | 1-0-0 |
Week 2 | 1-0-1 |
Week 3 | 1-1-1 |
Week 4 |  | 1-0-0
Week 5 |  | 1-0-1
Week 6 |  | 1-1-1
Week 7 |  | 2-1-1
Week 8 |  | 2-1-2
Week 9 |  | 2-2-2

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Table 18.

Laboratory controls during treatment with fumaric acid esters

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Table 19.

Tabular summary

Methotrexate

First approved in Germany

 Lantarel®
1991 (Psoriasis vulgaris)

 Metex® 7.5/10 mg
1992 (Psoriasis vulgaris)

 Metex® 2.5 mg
2004 (Psoriasis vulgaris)

Recommended control parameters
Complete blood count (Hb, HCT, differential blood count, platelets), renal function (serum creatinine, urea, urine sediment), liver values (serum transaminases), III-procollagen amino terminal propeptides

Recommended initial dosage
5–15 mg per week

Recommended maintenance dosage
5–22.5 mg per week depending on effect

Expected beginning of clinical effect
After 4–8 weeks

Response rate
PASI 75 in approximately 60% of the patients at the end of the induction phase of 16 weeks (LE 3)

Important contraindications (limited selection)
Absolute contraindications:

Desire to have children (for both men and women), pregnancy and nursing, inadequate contraception, drug consumption, alcoholism, known sensitivity to active ingredient methotrexate (e.g. pulmonary toxicity), bone marrow dysfunction, severe liver disease, severe infections, immunodeficiency, active peptic ulcers, hematologic changes (leucopenia, thrombocytopenia, anemia), renal failure

Relative contraindications:

Kidney disorders, liver disorders, history of arsenic consumption , chronic congestive cardio-myopathy, adiposity, old age, diabetes mellitus, history of hepatitis, lack of patient compliance, ulcerative colitis, diarrhea, NSAID use, gastritis

Important ADRs (limited selection)
Liver fibrosis/cirrhosis, pneumonia/alveolitis, bone marrow depression, renal damage, alopecia (reversible), nausea, weariness, vomiting, elevated transaminases, infection, gastrointestinal ulcerations, nephrotoxicity

Important drug interactions (limited selection)
Cyclosporine, salicylates, sulfonamides, probenecide, penicillin, colchicin, NSAIDs (naproxene, ibuprofene, etc.), ethanol, co-trimoxazole, pyrimethamine, chloramphenicol, sulfonamides, prostaglandin synthesis inhibitors, cytostatics, probenecide, barbiturates, phenytoin, retinoids, sulfonamides, sulfonylurea, tetracyclines, co-trimoxazol, chloramphenicol, dipyridamole, retinoids, ethanol, leflunomide

Other
Consistent avoidance of alcohol, X-ray of the lungs prior to beginning therapy

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Table 20.

Laboratory controls during treatment with MTX [137]

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Table 21.

Tabular summary

Acitretin
First approved in Germany | 1992 (Psoriasis vulgaris)
Recommended control parameters | Erythrocyte sedimentation rate (ESR), complete blood count, liver values, renal values, blood lipid values, pregnancy test, x-ray control of the bones in case of long-term therapy
Recommended initial dosage | 0.3–0.5 mg/kg BW per day for approximately 4 weeks, then 0.5–0.8 mg/kg BW
Recommended maintenance dosage | Individual dosaging dependent on the results and tolerance
Expected beginning of clinical effect | After 4–8 weeks
Response rate | Widely variable and dose-dependent, no definite statement possible, partial remission (PASI 75) in 25–75% of the patients (30–40 mg per day) (LE 3) in studies
Important contraindications (limited selection) | Renal and liver damage, desire to have children in female patients of child-bearing age, pregnancy, nursing, alcohol abuse, manifest diabetes mellitus, wearing of contact lenses, history of pancreatitis, hyperlipidemia requiring drug treatment
Important ADRs (limited selection) | Hypervitaminosis A (e.g., cheilitis, xerosis, nose-bleeding, alopecia, increased skin fragility)
Important drug interactions (limited selection) | Phenytoin, tetracyclines, methotrexate, alcohol, mini-pill
Other | Contraception up to 2 years after discontinuation in female patients of child-bearing age

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Table 22.

Laboratory controls during treatment with Acitretin

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Table 23.

Tabular summary

Climate/balneotherapy
First approved in Germany | Clinical experience with balneotherapy has existed for more than 200 years
Recommended control parameters | Regular skin inspection
Recommended initial dosage | Therapy regimens vary depending on the institution/location
Recommended maintenance dosage | Therapy regimens vary depending on the institution/location
Expected beginning of clinical effect | Varies greatly
Response rate | Varies greatly (LE 4)
Important contraindications | Dependent on modality selected
Important ADRs | Dependent on modality selected
Important drug interactions | Not applicable
Other | Balneotherapy and climate therapy are frequently combined

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